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Utility of CYP2D6 Genotyping to Improve the Efficacy and Safety of Tramadol

NCT05657704 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-12-20

No results posted yet for this study

Summary

Randomized clinical trial to evaluate the utility of CYP2D6 genotyping to improve the efficacy and safety of tramadol in the treatment of acute postoperative pain.

Phase IV and low-intervention trial To evaluate if the implementation of pharmacogenetics in clinical practice can help to improve the treatment of acute pain, increasing efficacy and reducing adverse reactions.

The main evaluation variable: This is a simple study, which does not differ from standard clinical practice and therefore we do not expect early ending of the study.

Conditions

  • Post-surgical Pain
  • Pain, Acute
  • Postoperative Pain

Interventions

DRUG

The patients in experimental group will be genotyped before surgery and treatment will be prescribed according to the CYP2D6 phenotype

Treatment will be prescribed according to the CYP2D6 phenotype. Normal Metabolizers (NM): Tramadol 100 mg every 8 hour; Ultrarapid Metabolizers (UM): Tramadol 50 mg every 8 hours Intermediate and poor metabolizers (IM/PM): dexketoprofen 25 mg every 8 hours

Sponsors & Collaborators

  • Hospital Universitario La Paz

    collaborator OTHER

  • Hospital Universitario Ramon y Cajal

    collaborator OTHER

  • Hospital Universitario Fundación Jiménez Díaz

    collaborator OTHER

  • Hospital Universitario San Juan de Alicante

    collaborator OTHER

  • Hospital Universitario de Burgos

    collaborator OTHER

  • Hospital San Carlos, Madrid

    collaborator OTHER

  • Puerta de Hierro University Hospital

    collaborator OTHER

  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657704 on ClinicalTrials.gov